Impact Of Dry Eye Severity On The Efficacy Of Crosslinked Hyaluronate Canalicular Filler Vs. Hydrogel Canalicular Plugs: A Sub Analysis Of The Half Dome Trial

Dry eye disease (DED) can be characterised by a deficiency in the quantity or quality of tears and tear film instability, with preservation of the tear film via canalicular occlusion offering a beneficial solution. In the HaLF DOME trial¹, a crosslinked hyaluronic acid (HA) canalicular filler (Lacrifill Canalicular Gel), was non-inferior to a hydrogel plug (Form Fit) in relieving DED symptoms, shown through improvement in mean Schirmer and Ocular Surface Disease Index (OSDI) scores from baseline. This sub-analysis evaluates the efficacy of Lacrifill compared to Form Fit in patient groups presenting with moderate and severe DED. This will provide further clarity on the efficacy of crosslinked HA in treating various severities of DED.

A prospective, multicentre, controlled, double-masked, randomized clinical study across 5 sites in the United States.

This sub-analysis focuses on OSDI scores collected from the previously published HaLF DOME trial. This clinical trial included adults (≥22 years) with an OSDI score of ≥23 and a Schirmer test result of ≤10 mm/5 minutes. Participants were randomised 2:1 to receive either crosslinked HA filler or hydrogel plugs, bilaterally inserted into the inferior canaliculi.

This sub-analysis looks at those patients with an OSDI score recorded at both baseline and 3 months (n=150/157), evaluating the proportion, at baseline, with a moderate (23-32) OSDI score and a normal (≤12) OSDI score at 3 months post-treatment, as well as the proportion, at baseline, with a severe (≥33) OSDI score and a normal or mild (≤22) OSDI score at 3 months post-treatment.

150 patients were included in this sub-analysis: 98 treated with HA filler and 52 with hydrogel plugs. Both groups showed similarly significant OSDI score improvements from baseline by month 3, with mean reductions of 27.3 and 25.3, respectively.

In patients with a moderate baseline OSDI score (n=27), HA filler showed a trend towards a greater number of patients achieving a normal score (53%, 9/17) compared to the hydrogel plug group (30%, 3/10) at 3 months.

In patients with a severe baseline OSDI score (n=123), treatment with HA filler produced a similar number of patients achieving a normal or mild score (63%, 51/81) compared to those treated with hydrogel plugs (59%, 25/42) at 3 months. Statistical superiority was not confirmed.

Lacrifill crosslinked HA filler was statistically non-inferior to hydrogel plugs in reducing dry eye symptoms in patients presenting with both moderate and severe OSDI scores at baseline. However, a trend of more patients with a moderate OSDI score at baseline and treated with HA filler achieving a normal OSDI score at 3 months was observed. This trend merits further investigation. Lacrifill crosslinked HA filler was shown to be an effective and well-tolerated treatment for dry eye disease in both moderate and severe disease cohorts.